NDA Resubmitted for Eliquis for Reduction of the Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation

Bristol-Myers Squibb and Pfizer announced that the FDA has acknowledged receipt of the New Drug Application (NDA) resubmission for Eliquis (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).

The FDA has deemed the resubmission a complete response to its June 22, 2012 Complete Response Letter that requested additional information on data management and verification from the ARISTOTLE trial.

The ELIQUIS NDA is based on the results of the ARISTOTLE and AVERROES studies. These clinical studies evaluated ELIQUIS in approximately 24,000 patients with NVAF. The ARISTOTLE trial compared apixaban to warfarin (Coumadin; Bristol-Myers Squibb), the standard of care, in more than 18,000 NVAF patients, while AVERROES compared apixaban to aspirin in 5,598 NVAF patients who were unsuitable for vitamin K antagonist (VKA) therapy.